Nitinol versus steel partially covered self-expandable metal stent for malignant distal biliary obstruction: a randomized trial.

BACKGROUND AND STUDY AIMS: Covered nitinol alloy self-expandable metal stents (SEMSs) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction. In a randomized, multicenter trial, we compared stent patency, patient survival, and adverse events in patients with partly covered stents made from steel or nitinol. PATIENTS AND METHODS: A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography (ERCP) to insertion of a steel or nitinol partially covered SEMS, with 200 patients in each group. The primary outcome was confirmed stent failure during 300 days of follow-up.  RESULTS: At 300 days, the proportion of patients with patent stents was 77 % in the steel group, compared with 89 % in the nitinol group (P = 0.01). Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group, in 30 versus 14 patients (P = 0.02). Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group (P = 0.01). Median patient survival (secondary outcome) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups, respectively (P = 0.59). CONCLUSIONS: The nitinol SEMS showed longer patency time, and the nitinol group had fewer patients with stent failure, compared with the steel SEMS group. We could not detect any differences between the two groups regarding survival time, and regarding adverse event rate.Clinical trial registration : NCT 00980889.

Are liver function tests, pancreatitis and cholecystitis predictors of common bile duct stones? Results of a prospective, population-based, cohort study of 1171 patients undergoing cholecystectomy.

OBJECTIVE: The purpose of this study was to explore the accuracy of elevated liver function values, age, gender, pancreatitis and cholecystitis as predictors of common bile duct stones (CBDS). METHODS: All patients operated on for gallstone disease over a period of 3 years in a Swedish county of 302,564 citizens were registered prospectively. Intraoperative cholangiography (IOC) was used to detect CBDS. RESULTS: A total of 1171 patients were registered; 95% of these patients underwent IOC. Common bile duct stones were found in 42% of patients with elevated liver function values, 20% of patients with a history of pancreatitis and 9% of patients with cholecystitis. The presence of CBDS was significantly predicted by elevated liver function values, but not by age, gender, history of acute pancreatitis or cholecystitis. A total of 93% of patients with normal liver function tests had a normal IOC. The best agreement between elevated liver function values and CBDS was seen in patients undergoing elective surgery without a history of acute pancreatitis or cholecystitis. CONCLUSIONS: Although alkaline phosphatase (ALP) and bilirubin levels represented the most reliable predictors of CBDS, false positive and false negative values were common, especially in patients with a history of cholecystitis or pancreatitis, which indicates that other mechanisms were responsible for elevated liver function values in these patients.

Covered versus uncovered self-expandable nitinol stents in the palliative treatment of malignant distal biliary obstruction: results from a randomized, multicenter study.

BACKGROUND: Covered biliary metal stents have been developed to prevent tumor ingrowth. Previous comparative studies are limited and often include few patients. OBJECTIVE: To compare differences in stent patency, patient survival, and complication rates between covered and uncovered nitinol stents in patients with malignant biliary obstruction. DESIGN: Randomized, multicenter trial conducted between January 2006 and October 2008. SETTING: Ten sites serving a total catchment area of approximately 2.8 million inhabitants. PATIENTS: A total of 400 patients with unresectable distal malignant biliary obstruction. INTERVENTIONS: ERCP with insertion of covered or uncovered metal stent. Follow-up conducted monthly for symptoms indicating stent obstruction. MAIN OUTCOME MEASUREMENTS: Time to stent failure, survival time, and complication rate. RESULTS: The patient survival times were 116 days (interquartile range 242 days) and 174 days (interquartile range 284 days) in the covered and uncovered stent groups, respectively (P = .320). The first quartile stent patency time was 154 days in the covered stent group and 199 days in the uncovered stent group (P = .326). There was no difference in the incidence of pancreatitis or cholecystitis between the 2 groups. Stent migration occurred in 6 patients (3%) in the covered group and in no patients in the uncovered group (P = .030). LIMITATIONS: Randomization was not blinded. CONCLUSIONS: There were no significant differences in stent patency time, patient survival time, or complication rates between covered and uncovered nitinol metal stents in the palliative treatment of malignant distal biliary obstruction. However, covered stents migrated significantly more often compared with uncovered stents, and tumor ingrowth was more frequent in uncovered stents.

Correlation between plasma calcium, parathyroid hormone (PTH) and the metabolic syndrome (MetS) in a community-based cohort of men and women.

CONTEXT: In recent years, an association has been noted between several abnormalities that characterize the metabolic syndrome (MetS) and primary hyperparathyroidism (pHPT). These abnormalities include dyslipidaemia, obesity, insulin resistance and hypertension. The correlations between plasma calcium, parathyroid hormone (PTH) and the variables in the MetS in a normal population are still unclear. OBJECTIVE: To describe correlations between plasma calcium and PTH and the various abnormalities present in the MetS in a healthy population. DESIGN: We studied 1016 healthy individuals from the Prospective Investigation of the Vasculature in Uppsala Seniors (PIVUS) population of 70 years old, by means of plasma analyses of calcium, PTH, creatinine, lipids, insulin and glucose, as well as by standardized blood pressure measurements. Further, body mass index (BMI) and waist circumference were determined. RESULTS: The more National Cholesterol Education Program (NCEP) criteria for the MetS that were met, the higher the s-PTH and albumin-corrected s-calcium. Further, positive correlations between plasma calcium and BMI (P = 0.0003), waist circumference (P = 0.0009) and insulin resistance (P = 0.079) were found. PTH and BMI (P < 0.0001), waist circumference (P < 0.0001), systolic blood pressure (P = 0.0034), diastolic blood pressure (P = 0.0008), serum triglycerides (P = 0.0003) and insulin resistance (P = 0.0003) were positively correlated, whereas serum high density lipoproteins (HDL) (P = 0.036) and PTH were negatively correlated. CONCLUSIONS: We conclude that PTH correlates with several of the metabolic factors included in the MetS within a normocalcaemic population. In addition, individuals with mild pHPT present significantly more NCEP criteria for MetS. We postulate that increased levels of PTH in pHPT may be associated with the increased cardiovascular morbidity and mortality seen in pHPT.

Low recurrence rate after laparoscopic (TEP) and open (Lichtenstein) inguinal hernia repair: a randomized, multicenter trial with 5-year follow-up.

OBJECTIVES: To compare a laparoscopic (totally extraperitoneal patch (TEP)) and an open technique (Lichtenstein) for inguinal hernia repair regarding recurrence rate and possible risk factors for recurrence. SUMMARY BACKGROUND DATA: Laparoscopic hernia repair has been introduced as an alternative to open repair. Short-term follow-up suggests benefits for those patients operated with a laparoscopic approach compared with open techniques; ie, less postoperative pain and a shorter convalescence period. Long-term results, however, are less well known. METHODS: The study was conducted as a multicenter randomized trial with a 5-year follow-up. A total of 1512 men aged 30 to 70 years, with a primary unilateral inguinal hernia, were randomized to either TEP or Lichtenstein repair. RESULTS: Overall, 665 patients in the TEP group and 705 patients in the Lichtenstein group were evaluable. The cumulative recurrence rate was 3.5% in the TEP group and 1.2% in the Lichtenstein group (P = 0.008). Test for heterogeneity revealed significant differences between individual surgeons. The exclusion of 1 surgeon, who was responsible for 33% (7 of 21) of all recurrences in the TEP group, lowered the cumulative recurrence rate to 2.4% in this group, which was not statistically different from that of the Lichtenstein group. CONCLUSIONS: The recurrence rate for both TEP and Lichtenstein repair was low. A higher cumulative recurrence rate in the TEP group was seen at 5 years. Further analysis revealed that this could be attributable to incorrect surgical technique.

High success rate of parathyroid reoperation may be achieved with improved localization diagnosis.

INTRODUCTION: Because of the difficulty of reoperative parathyroid surgery, preoperative imaging studies have been increasingly adopted. We report the use of consistently applied localization diagnosis to yield high success rates in parathyroid reoperations. METHODS: Parathyroid reoperation was performed after previous parathyroid surgery in 144 patients with nonmalignant hyperparathyroidism (HPT) between 1962 and 2007. From the year 2000, 46 patients who underwent parathyroid reoperation and 14 patients who were subjected to thyroid surgery before primary parathyroid operation were investigated with sestamibi scintigraphy (MIBI), 11C-methionine PET/CT (met-PET), surgeon-performed ultrasound (US), US-guided fine-needle aspiration biopsy (US-FNA), and selective venous sampling (SVS) with rapid PTH (Q-PTH) analyses. When imaging was considered adequate, additional studies were generally not obtained. RESULTS: Reversal of hypercalcemia was achieved by reoperation in 134 of 144 (93%) of all patients with previous parathyroid surgery. In patients operated from year 2000, MIBI had 90% sensitivity and 88% predictive value, met-PET 79% sensitivity and 87% predictive value, and US 72% sensitivity and 93% predictive value. SVS with Q-PTH analyses provided accurate localization or regionalization in 11 of 11 recently selected patients. Q-PTH analyses in fine-needle aspirations verified parathyroid origin of excised specimens, and intraoperative Q-PTH helped decide when operations could be terminated. In patients subjected to the algorithm of imaging procedures, reversal of hypercalcemia and apparent cure was obtained after the reoperation in 45 of 46 patients with previous parathyroid surgery, implying a success rate of 98%, and in all patients with previous thyroid surgery. CONCLUSIONS: Reoperative parathyroid surgery is challenging. Results can be improved by consistently applied sensitive methods of preoperative imaging, and reoperative procedures may then achieve nearly the same success rates as primary operations.